The U.S. Food and Drug Administration today announced a new initiative to address safety problems associated with external infusion pumps, which are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner.

As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance today of a new draft guidance and letter to infusion pump manufacturers. FDA is also announcing a May public workshop on infusion pump design, and launching a new Web page devoted to infusion pump safety.

“These pumps often provide critical fluids to high-risk patients, so failures have significant implications,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “It is time for a more comprehensive approach than we’ve taken to date.”

Infusion pumps are widely used in hospitals, other clinical settings, and the home. The devices allow a greater level of control, accuracy, and precision in drug delivery, and help to reduce medication errors.

However, infusion pumps also have been the source of persistent safety problems. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.

The most common types of reported problems have been related to:

software defects, including failures of built-in safety alarms;

user interface issues, such as ambiguous on-screen instructions that lead to dosing errors; and

mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires.

Failures of infusion pumps have been observed across multiple manufacturers and pump types. The FDA says that many of the reported problems appear to be related to deficiencies in device design and engineering.

As part of its initiative, the FDA published draft guidance today recommending that infusion pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the devices.

Also today, the FDA issued a letter to infusion pump manufacturers, informing them that they may need to conduct additional risk assessments to support clearance of new or modified pumps.

In addition to alerting them of this intended change, the letter offers manufacturers the option of submitting their infusion pump software codes to experts at the FDA for static analysis prior to premarket review. Static analysis is a diagnostic technique that can help detect software problems early in the device development process. The agency previously invited manufacturers to make use of an open-source software safety model developed through the Generic Infusion Pump project, an ongoing collaboration with outside researchers aimed at improving pump design.

The FDA’s public workshop will be held May 25-26, 2010. Participants will discuss observed safety problems, and explore opportunities to work with others, including foreign regulators, to improve the design of infusion pumps on the market or in development, in order to reduce pump malfunctions and errors.

“Working with industry and users, we can help develop safer, more effective infusion pumps and improve patient care,” said Shuren.

The agency’s new infusion pump safety Web page features basic information about infusion pumps and steps that patients and healthcare professionals can take to prevent and report safety problems, even before new or redesigned pumps are brought to the market.

Advice to Users

To help reduce infusion pump risks, the FDA asks clinicians to consider the following general strategies.

Plan ahead and be ready to respond in the event of a pump failure.

Label infusion pump channels and tubing to prevent errors.

Check infusion pump settings and monitor patients for signs of over- or under-infusion.